Validation Engineer Job Description
Validation engineer
provides memory tuning, HDMI/DP SI and HDMI Protocol test report for customers.
Validation Engineer Duties & Responsibilities
To write an effective validation engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included validation engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Define set of test cases to execute during Test Cycle and perform execution of this cycle
Collect results from tests execution, prepare reports
Analyze results and report data about defects discovered during validation cycle
Design, Develop and Execute Validation Testing as required on projects including deliverables such as but not limited to Test Plans, Test Results, and Test Reports
Support the project team in root cause analysis on Validation Test Issues
Perform other duties as assigned by the Sr
Participate as required in project activities
Co-ordinate the individual tasks required to validate processes equipment
Participate, when required, as a member of multidisciplinary site teams, Cross Functional Investigation Team
Responsible for determining the implications of validations upon
Validation Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation Engineer
List any licenses or certifications required by the position: ISTQB, ASQ, ISO, DFSS, PMP, ISEB, CQE, CCNA, HEPA, CIP
Education for Validation Engineer
Typically a job would require a certain level of education.
Employers hiring for the validation engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Computer Science, Education, Electrical Engineering, Chemical Engineering, Mechanical Engineering, Medical, Chemistry
Skills for Validation Engineer
Desired skills for validation engineer include:
SATA
Server and SoC platform architectures is desired
Python
Memory
USB
Statistics
HDMI
Display Port
PCI-Express
C
Desired experience for validation engineer includes:
Temperature mapping (Kaye) experience is a plus
Provide oversight to site functional teams to ensure they maintain compliance with all documented validation policies and procedures within the plant
Degree in Science/Engineering with 3+ years experience in a similar role within the Medical Devices or related Healthcare industry
Strong knowledge of ISO and FDA quality requirements
Understanding of the project management lifecycle
Experience with Proficy iHistorian, Wonderware Intouch, Rockwell Automation Contrologix is advantageous
Validation Engineer Examples
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Validation Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a validation engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation engineer
- Drafting and updating manufacturing specifications and procedures
- Drafting protocols & completion reports
- Create and revise Design Verification and Validation (V&V) Procedures
- Participate in Design Verification and Validation Procedure Reviews
- Perform dry runs and formal Verification and Validation (V&V) activities as required
- Perform remediation’s of V&V results as required
- Computer Software Validation (CSV) Test / Protocol execution
- Oversee the conduct of Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, PQ)
- Perform Dry run –Data Set Up (Role based), test script/ protocol execution for CAPA and Investigations, per Business, Functional Requirements and User Requirements and identify deviations (TDRs) – system, design, logic/ workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system
- Ensure all GMP equipment/instruments and devices are in a qualified/certified state
Qualifications for validation engineer
- Experience in aspects of Engineering, QA, validation and ISO 13485
- A science, engineering or appropriate degree
- Validation of equipment & utilities, including filling & finishing
- Product performance qualifications
- Cleaning validation/verification
- Working knowledge of applicable regulations and guidelines, to include ISO 13485 and QSR/CFR Parts 820, , 21 CFR Part 11, and other relevant guidelines
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Validation Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of validation engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation engineer
- Responsible for temperature mapping of facility Controlled Temperature Units, Stability Chambers, Warehouse Space, Autoclave, Incubators, Humidity Controlled Rooms/Glove boxes and Cold Rooms
- Execution of IQ, OQ and PQ on new/revised processes as required
- Project management tasks include holding validation kickoff meetings, documenting and managing risk, maintain action item lists and holding validation meetings
- Uses all validation and technical training to identify potential reliability concerns
- Optimize the information flow to gain efficiency and time to market
- Oversee Manufacturing, Quality Control, Facilities, IT and Materials Management in the implementation of validation activities
- Develop, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance client and industry standards
- Assist with client and FDA audits by explaining validation and qualification activities performed at the site
- Implement validation strategy and approach taking into account the relevant GxP requirements
- Manage and control validation documentation in collaboration with QA teams
Qualifications for validation engineer
- Degree level qualification in Engineering/Electronics
- Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry
- Desirable project management qualification such as PMP
- Engineering or science Degree
- Knowledge of Computer System Validation will be a distinct advantage
- A Six Sigma qualification will be a distinct advantage
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Validation Engineer Job Description
Job Description Example
Our company is looking to fill the role of validation engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for validation engineer
- Active member in product development teams
- Perform bench test and characterization of Power Management Devices (PMIC)
- Develop test plan based on design specifications
- Work as part of cross functional team that includes design, applications, test and quality engineers
- Perform parametric and functional measurements using bench equipment such as DMMs, Oscilloscopes, Power Supplies
- Collect bench data, perform data analysis and generate reports to summarize test results
- Support design & development engineers in the completion of FMEA based risk analysis, identifying Failure Modes and Validation Controls
- Collate the output of system and component FMEA's to identify requirements for rig test, simulation, engine test, and in field validation needs
- Proactively address potential Failure Modes through design
- Develop detailed test and instrumentation requirements
Qualifications for validation engineer
- Leader auditor qualification would be a distinct advantage
- Knowledge of Test Method Validation will be a distinct advantage
- Experience in Design Assurance with the ability to develop clinical relevant validated tests methods
- Good PC skills and the ability to use Microsoft Project to track and manage significant projects
- Responsable de manejo y estadística aseguramiento de calidad
- Experience in the implementation and validation of stand-alone IT applications complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems
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Validation Engineer Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of validation engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation engineer
- Interfaces with compliance groups inside of IT to ensure the infrastructure qualification process
- Works with project managers to establish work scheduling plans in support of project schedules and participates in project meetings
- Develop project plan for local site response in order to meet corporate timeline
- Contribute to the planning and execution of components of the measurement system development process, which may include method revision, enhancement or a defined piece of a larger project
- Investigate design improvement suggestions
- Be responsible for assuring product performance, reliability, claims, and safety in product development from conception through production start
- Document and execute process validations on manufacturing equipment
- Provide technical engineering support
- Interface with customers to help solve technical issues
- Knowledge of IQ, OQ and PQ
Qualifications for validation engineer
- Usage of any Document Management System such as Qdoc, Documentum, Trackwise
- Application server middleware
- Prefer Validation experience with Cleaning Validation
- Bachelor’s / Master’s degree in Electronics/Electrical/Instrumentation/Power Engineering with minimum 2 year of experience in process industry preferably in power plant
- Basic knowledge of Distributed Control Systems and Power Plant/ Water and Waste Water process
- Good communication, interpersonal skill and drive for results
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Validation Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of validation engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation engineer
- Responsible for the management of consultants used to support plant startup
- Validation Automation Development
- Support the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
- Support Tech Transfer activities for new products and product changeovers
- Support reliability engineering for production and support equipment
- Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
- Lead/Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
- Lead/Support the development and execution of commissioning, validation and qualification documents and activities
- Analyzes assignments and determines engineering specifications which must be fulfilled for routine problems or projects
- Compiles and furnishes necessary information to document the design solution required for building of prototypes and adoption of the design with possible involvement of other functional engineers, supply management and/or supplier personnel
Qualifications for validation engineer
- Willing to travel India and abroad
- Should be able to resolve basic technical matters
- Self-motivation and to accept challenging assignments
- 3-5 years’ experience in Medical Device manufacturing is key
- Ability to compose professional and engineering documentation
- Ability to manage time and projects effectively while setting and meeting aggressive schedules